Accessory device, a patient immobilization system, and a method of forming a patient immobilization system

ABSTRACT

An accessory device and an immobilization system including the device are provided for positioning at least a portion of a patient&#39;s body relative to an immobilization device including a low temperature thermoplastic sheet. The accessory device may include a patient fixation portion and a lock portion. The patient fixation portion is attached to or inserted in the patient during use. The lock portion may extend distally from the patient fixation portion generally along a lock portion axis. The lock portion includes a shape, surface feature, or configuration, such that the low temperature thermoplastic sheet may be conformed to the outer surface of the lock portion of the accessory device, such that unintended separation of the accessory device from the low temperature thermoplastic sheet is prevented. Methods of forming the accessory device and immobilization system are also provided.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/602,372, filed May 23, 2017 which claims priority to and benefit ofU.S. Provisional Patent Application No. 62/340,147, filed May 23, 2016,the contents of each of which are incorporated herein by reference.

FIELD OF THE INVENTION

This invention relates to an accessory device for positioning a patient,an immobilization system, and a method of forming an immobilizationsystem for immobilizing at least a portion of a patient's body.

BACKGROUND OF THE INVENTION

In radiotherapy treatment of cancer, low temperature (LT) thermoplasticimmobilization preforms in the form of sheets are often formed over apatient's body to limit patient motion during imaging and/or treatment.Examples of LT thermoplastic materials include Aquaplast and Fibreplast(manufactured by Qfix Systems, LLC of Avondale, Pa.).

Over the years, various advances have been made to improveimmobilization systems. For example, US-2016-0095739-A1 discloses a biteplate that is used in conjunction with LT thermoplastic for immobilizinga patient's head. Nevertheless, there remains a need for furtherimprovements in immobilization systems.

SUMMARY OF THE INVENTION

According to one aspect of the present invention, an accessory device isconfigured to position a patient relative to an immobilization deviceincluding a low temperature thermoplastic sheet. The accessory devicemay include a patient fixation portion configured for fixation on orinsertion into the patient during use and a lock portion extendingdistally from the patient fixation portion generally along a lockportion axis. The accessory device may be configured to be engaged by aproximal surface of the low temperature thermoplastic sheet by formingthe proximal surface of the low temperature thermoplastic sheet aroundthe lock portion of the accessory device, such that the proximal surfaceof the low temperature thermoplastic sheet conforms to the lock portionand the engagement prevents unintended separation of the accessorydevice from the low temperature thermoplastic sheet during use.

According to another aspect of the present invention, the accessorydevice may be combined with a low temperature thermoplastic sheet toprovide an immobilization system configured to immobilize a patient.

According to yet another aspect of the present invention, a method offorming an immobilization system configured to immobilize at least aportion of the patient's body is provided. The method comprises thesteps of attaching or inserting a patient fixation portion of anaccessory device on or in the patient, positioning a proximal surface ofa low temperature thermoplastic sheet of an immobilization deviceadjacent a lock portion of an accessory device extending distally fromthe patient fixation portion, forming the low temperature thermoplasticsheet of the immobilization device about the portion of the patient'sbody, and forming the proximal surface of the low temperaturethermoplastic sheet around the lock portion of the accessory device,such that unintended separation of the accessory device from the lowtemperature thermoplastic sheet is prevented.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is best understood from the following detailed descriptionwhen read in connection with the accompanying drawings, with likeelements having the same reference numerals. When a plurality of similarelements are present, a single reference numeral may be assigned to theplurality of similar elements with a small letter designation referringto specific elements. When referring to the elements collectively or toa non-specific one or more of the elements, the small letter designationmay be dropped. This emphasizes that according to common practice, thevarious features of the drawings are not drawn to scale unless otherwiseindicated. On the contrary, the dimensions of the various features maybe expanded or reduced for clarity. Included in the drawings are thefollowing figures:

FIG. 1 is a general schematic of an accessory device according to anaspect of the present invention;

FIG. 2A is a perspective view of a first embodiment of an accessorydevice according to an aspect of the present invention;

FIG. 2B is a top plan view of the embodiment of FIG. 2A;

FIG. 3A is a side view of a second embodiment an accessory deviceaccording to an aspect of the present invention;

FIG. 3B is a top plan view of the embodiment of FIG. 3A;

FIG. 4A is a side view of a third embodiment of an accessory deviceaccording to an aspect of the present invention;

FIG. 4B is a top plan view of the embodiment of FIG. 4A;

FIG. 5A is a side view of a cross-section of a fourth embodiment of thepresent invention along axis I-I in FIG. 5B;

FIG. 5B is a top plan view of the fourth embodiment of an accessorydevice according to an aspect of the present invention;

FIG. 6A is a side view of a fifth embodiment of an accessory deviceaccording to an aspect of the present invention;

FIG. 6B is a top plan view of the embodiment of FIG. 6A;

FIG. 7A is a side view of a sixth embodiment of an accessory deviceaccording to an aspect of the present invention;

FIG. 7B is a top plan view of the embodiment of FIG. 7A;

FIG. 8A is a side view of a seventh embodiment of an accessory deviceaccording to an aspect of the present invention;

FIG. 8B is a top plan view of the embodiment of FIG. 8A;

FIG. 9 is a side view of the locking feature of the embodiment of FIG.8A on which a portion of an LT thermoplastic material has been crimped;

FIG. 10A is a top plan view of an eighth embodiment of an accessorydevice according to an aspect of the present invention;

FIG. 10B is a side view of the embodiment of FIG. 10A;

FIG. 11 is a side view of the cross section of the embodiment of FIG. 6Aon which a portion of an LT thermoplastic material has been crimped;

FIG. 12 is a side view of the cross section of the embodiment of FIG. 8Aon which a portion of an LT thermoplastic material has been crimped;

FIG. 13 is a side view of a ninth embodiment of an accessory deviceaccording to an aspect of the present invention;

FIG. 14 is a side view of tenth embodiment of an accessory deviceaccording to an aspect of the present invention orally inserted in apatient;

FIG. 15A is a top plan view of a ninth embodiment of an accessory deviceaccording to an aspect of the present invention; and

FIG. 15B is a front view of a patient in which a plurality of accessorydevice having been inserted, including the embodiment of FIG. 15A.

DETAILED DESCRIPTION OF THE INVENTION

Although the invention is illustrated and described herein withreference to specific embodiments, the invention is not intended to belimited to the details shown. Rather, various modifications may be madein the details within the scope and range of equivalents of the claimsand without departing from the invention.

Bite plates, ear inserts, and other accessories may be incorporated intoimmobilization systems to improve the quality of immobilization andrepeatability from simulation through each treatment fraction, such asthe apparatus disclosed in U.S. Pat. No. 6,945,251. Such accessories canbe either attached through multi-component mechanical fasteners orthrough secondary adhesive application used to bond the accessory to aLT thermoplastic. In some instances, however, such systems encounterdifficulty associated with attaching the accessories to the surface ofthe LT thermoplastics because the surface is typically a low friction,anti-stick surface, so that the material does not stick to the patientor to itself.

In US-2016-0095739-A1, a bite plate is inserted from the outside of theLT thermoplastic. While this solution represents an improvement, thesize of the overall attached accessory can be limited and detailedcontouring of anatomical features, such as the ear, may be difficult insome instances.

The accessory device according to the various embodiments of thisinvention comprises a piece, or lock portion, that is mechanicallyfastened to an LT thermoplastic immobilizer through a direct mechanicalfastening created by the LT thermoplastic immobilizer. The accessorydevice includes a portion that is applied to or inserted in the patient.The accessory device also includes a locking feature that is configuredto allow a portion of the LT thermoplastic to be wrapped around thelocking feature. The accessory device may be of single-piece design toprovide a less complex system that is easier for the clinician to useand reduces the number of parts that can be lost or misplaced.

The accessory device includes a patient fixation portion designed for avariety of applications familiar to one skilled in the art. Theseinclude, but are not limited to, a mouthpiece, ear insert, nasionfixator, tongue block, etc.

The present invention also includes methods of immobilizing a patient byattaching an accessory device to a thermoplastic preform. In oneembodiment, the accessory device comprises a patient fixation portionand a locking feature. The locking feature can be of several forms asdescribed later herein. According to one method of the presentinvention, the accessory device may include a patient fixation portionin the form of a mouthpiece placed in the patient's mouth, and thepatient is allowed to bite down on the mouthpiece. The locking featuremay be configured such that it extends out of the patient's mouth.

Pre-heated LT thermoplastic sheet is then formed over the lockingfeature and the patient and attached to a base plate to keep the preformin place as it cools. Base plates on other immobilization hardware (suchas those incorporated in the Portrait and Encompass systems manufacturedby Qfix Systems, LLC of Avondale, Pa.) are optionally used.

While the LT thermoplastic material is still soft, a portion of thematerial is formed or wrapped around the locking feature of theaccessory device. Once cooled and hardened, the LT thermoplasticmaterial will be secured as a result of pinching, clamping, or clutchingforces of the material about the locking feature. It is preferred that aclose mechanical contact is provided between the LT thermoplasticmaterial and the locking feature to provide a rigid mechanicalinterlock. This pinching, crimping, or compressing can be accomplishedmanually by hand or with a tool, such as a clothes pin, a hemostat,pliers, or any other such tool as would be known to one skilled in theart.

The patient fixation portion of the accessory device may be made of arigid, semi-rigid, or flexible material. In addition, the patientfixation portion may be made from a reformable material, such asAquaplast or Fibreplast, that is able to conform or assume the shape ofa patient's mouth to promote comfort as well as the ability torepeatedly remove and replace the mask in the same position. The lockingfeature of the accessory device may comprise either the same ordifferent material than the patient fixation portion. For example, inone embodiment, the locking feature may be made of a rigid material, ora material that is more rigid than the patient fixation portion, so thatthe shape of the locking feature is not malleable or susceptible tochanging shape during fixation to the LT thermoplastic material.Alternatively, in another embodiment, the locking feature may be asmalleable or more malleable than the patient fixation portion of thefixation device, so that the locking feature may be molded duringfixation to the LT thermoplastic material. The inclusion of channels andport to apply a vacuum may be included in the patient fixation portionin yet another embodiment of the invention described in greater detailbelow.

The locking feature of the accessory device according to the variousembodiments of the present invention may be configured in a variety ofgeometries. It is preferred that the geometry allows preheated/softenedLT thermoplastic material to be wrapped around the locking feature sothat the accessory device and LT thermoplastic material are fixedlycoupled to each other when the LT thermoplastic material cools and/orhardens. It is particularly preferred that the connection between thelocking feature and the LT thermoplastic material firmly locks all sixdegrees of freedom of the accessory with respect to the LT thermoplasticmaterial. For example, the geometry of the locking feature may be suchthat the shape minimizes any air gaps between the locking feature andthe hardened LT thermoplastic material. The shape and size of thelocking feature may be selected based on the desired connection betweenthe accessory device and the LT thermoplastic material and the specificapplication for the patient.

Referring now to the figures, various embodiments of an accessory device18 according to the present invention are illustrated. In FIG. 1 , ageneral schematic illustrating the relative positions of the patientfixation portion 17 and a lock feature 19 of an accessory device 15 isprovided. The patient fixation portion 17 is represented as a sphere;however, the patient fixation portion 17 is preferably configured toconform to patient specific anatomy depending on the location that thepatient fixation portion will be applied or inserted. For example, inthe remaining figures, various embodiments of the present invention areillustrated in which the patient fixation portion is intended for oralinsertion; however, as noted above, the patient fixation portion of theaccessory device may be configured for use as an ear insert, nasionfixator, or tongue block, for example.

In FIGS. 2A and 2B, an accessory device 18 according to a firstembodiment of the present invention is provided. The accessory device 18is of a single piece design and includes a patient fixation portion 20in the form of a mouthpiece and a locking feature 22. The patientfixation portion 20 is U-shaped to provide an area that is substantiallyproportional to the area of a patient's bite. Projecting from a frontsurface 21 of the patient fixation 20 is a locking feature 22. Thelocking feature 22 of the first embodiment includes a substantiallyuniform width, but a variable height because the locking feature 22includes a plurality of ridges 24. The undulations on the top and bottomsurface of the locking feature 22 provide an area for forming aninterlocking surface with an LT thermoplastic material, therebypreventing accessory device 18 from being withdrawn from the LTthermoplastic material after a softened LT thermoplastic material hasbeen crimped onto at least one ridge 24 and along the sides of thelocking feature 22 while the material is allowed to harden.

In FIGS. 3A to 8B, several embodiments of the present invention areillustrated. The accessory devices (118, 218, 318, 418, 518, 618)according to the additional embodiments are also a single piece designand include a patient fixation portion (120, 220, 320, 420, 520, 620)that is substantially similar to the first embodiment. The additionalembodiments also include locking features (122, 222, 322, 422, 522, 622)that project from a front surface (121, 221, 321, 421, 521, 621) of thepatient fixation portion (120, 220, 320, 420, 520, 620); however, theshape of the various locking features differ.

For examples in FIGS. 3A, 3B, 4A, and 4B, the locking feature 122, 222includes a plurality of notches 124, 224 of different sizes and shapeslocated at different locations along the sides of the locking feature122, 222. Alternatively, one or more openings, such as a hole, bore, oraperture, may be provided within the locking feature, such as thesquare-shaped hole 324 in the locking feature 322 in the embodiment ofFIGS. 5A and 5B. The shape, size, and thickness of the hole should beselected to allow for LT thermoplastic material to substantially fillthe hole when crimped onto the locking feature. Alternatively, thelocking feature may be provided with one or more projections. Forexample, the locking feature may be T-shaped, similar to the embodimentsin FIGS. 6A to 6B. Other shapes may include, but are not limited to,Y-shapes, X-shapes, fan shapes, bow-tie shapes, ring shapes, oblongshapes, rhombus (lozenge) shapes, etc. The projections (424) may extendin the transverse direction, the projections (524) may extend in thesuperior/inferior direction, or at any angle about any axis, as long asthe LT thermoplastic material may be crimped around the locking featureand air gaps around the locking feature are minimized, i.e. contactbetween the LT thermoplastic material and the outer surface of thelocking feature is maximized.

The embodiment of FIGS. 7A and 7B having the projections in thesuperior/inferior direction also provides an additional advantage duringimaging and radiotherapy. For example, the projections may serve asreference markers for optical tracking systems, such OSMS and AlignRTfrom VisionRT, as well as with the Sentinel system from C-Rad. Aligningthe locking feature longitudinally (superior to inferior) may keep thelocking feature from blocking the main zero degree camera's view of thepatient's facial anatomy. At the same time, it may provide lateralcameras with a feature that can potentially be used for tracking.Alternatively, the locking feature may be L-shaped instead of T-shaped,so that the locking feature projects away from the patient's nose 920,such as locking feature 918 in FIG. 14 , which may provide better accessfor optical tracking systems.

As would be understood by one of skill in the art, the location andshape of the various features on the surface of the locking feature maybe varied, as long as the locking feature is provided with a surfacethat will prevent the accessory device from being withdrawn from ahardened LT thermoplastic material when the accessory device is in theinstalled condition, as illustrated in FIGS. 11 and 12 . As shown inFIG. 11 , the lock portion 322 does not penetrate the low temperaturethermoplastic sheet 630. Also as shown in FIG. 12 , the lock portion 624does not penetrate the low temperature thermoplastic sheet 630.

As illustrated in the figures, the locking feature is shown projectingfrom the midpoint of the front surface of the patient fixation portion;however, as would also be appreciated by those of skill in the art, oneor more locking features may project from various locations on the frontsurface of the patient fixation portion in different directions. It ispreferred that a plurality of locking features extend from the frontsurface of the mouthpiece at different angles, so that the accessorydevice is not limited to uses wherein the patient is in the supineposition. This may also be achieved with a single locking feature, forexample, if the accessory device is of a two-part design in which thelocking feature is allowed to slide or rotate relative to the frontsurface of the mouthpiece.

Yet another embodiment of a present invention is provided in FIGS. 8Aand 8B. Again, the accessory device 618 is essentially the same as theprevious embodiments. The accessory device 618 comprises a patientfixation portion in the form of a U-shaped mouthpiece 620 having a frontsurface 621 from which a locking feature 622 extends. In the embodimentof FIGS. 8A and 8B, the locking feature is in the form of a wedge withridges, e.g. an “inverted Christmas tree”. This configuration (as wellas others) can benefit from a forming tool to allow the clinician toform the LT thermoplastic material into all of the folds of the lockingfeature. This embodiment shows an adhesive coating (625) on a surface(626) of the engaging end portion (624).

FIG. 9 demonstrates how a tool may be provided to aid in the applicationof the softened LT thermoplastic material 630 to the locking featureduring forming. The tool 640 may be in the form of pliers or similarcrimping device, wherein the crimping end of the tool includes asimilarly shaped surface to the engaging end portion 624 of the lockportion 622, which extends distally from a bite portion (not shown)generally along a lock portion axis. This maximizes the contact betweenthe inner surface of a portion of the LT thermoplastic material 630 andthe engaging end portion 624 of the lock portion 622. To furtherminimize the potential for air gaps, pressure may be maintained usingthe tool until the LT thermoplastic material hardens around the lockportion 622. The lock portion 622 may also include a stem portion 628connecting the lock portion 624 to the bite portion of the accessorydevice. The stem portion 628 is preferably sufficiently long to preventthe potential of the tool 640 pinching the patient's flesh. The engagingend portion 624 may have a variable cross-sectional area along andorthogonal to the lock portion axis. As would be appreciated by those ofskill in the art, the engaging end portion of the lock portion mayalternatively have a generally uniform cross section along andorthogonal to the lock portion axis, but provided, for example, with acoiled or twisted configuration to prevent unintended separation of theaccessory device from the low temperature thermoplastic sheet in theengaged condition.

The accessory device may be configured to be engaged by a proximalsurface 650 of the low temperature thermoplastic sheet 630 by formingthe proximal surface 650 of the low temperature thermoplastic sheetaround the engaging end portion 624 of the lock portion 622 of theaccessory device, such that the proximal surface 650 of the lowtemperature thermoplastic sheet 630 contacts the reduced cross-sectionalarea of the engaging end portion 624 and the engagement preventsunintended separation of the accessory device from the low temperaturethermoplastic sheet during use. As shown in FIG. 9 , in the engagedcondition, the lock portion 622 does not penetrate the low temperaturethermoplastic sheet 630.

In another embodiment of the present invention illustrated in FIGS. 10Aand 10B, an accessory device 718 includes a patient fixation portion inthe form of a mouthpiece 720 with an integrated palate vacuum outlet724. The locking feature 722 has a configuration similar to the firstembodiment of the present invention described above; however, the vacuumsystem can be adapted to any of the aforementioned configurations of thelocking feature. It is often desirable to be able to make a customimpression of the upper palate and/or teeth of the patient. This can beparticularly beneficial in edentulous patient cases (patients withoutteeth). A system which allows a vacuum to be pulled between theimpression and the upper palate may be incorporated in the embodimentsof the present invention. Such a system is described in U.S. Pat. No.5,797,924, the contents of which are incorporated herein by reference.In the embodiment illustrated in FIGS. 10A, air passages 723 areprovided in the mouthpiece 720 of the accessory device 718, such that avacuum can be drawn between the bite portion and the patient's upperpalate. The air passages 723 are fluidly connected to a palate vacuum724 outlet in the locking feature 722 such that air may pass through theLT thermoplastic material and out through the outlet 724. A vacuum tube(not shown) may be attached to the palate vacuum 724 outlet on theoutside of the immobilization mask.

In yet another embodiment of the present invention illustrated in FIG.13 , an accessory device 818 includes a locking feature 822 in the formof a post extending from the front surface 821 of a patient fixationportion in the form of a mouthpiece 820. The post may be coated with anadhesive substance that will adhere to the LT thermoplastic material.For example, a coating of poly-caprolactone (PCL) will allow the portionof the LT thermoplastic material in contact with the locking feature tostick adhesively to the accessory device. As would be understood bythose of skill in the art, the combination of an adhesive with any ofthe aforementioned configurations for the locking feature or variationsthereof would further facilitate fixation of the accessory device to thehardened LT thermoplastic material.

In yet another embodiment of the present invention illustrated in FIGS.15A, an accessory device 1018 may optionally include fiducial markers1030 in various locations, such as the lock portion 1022 or the patientfixation portion 1020 of the accessory device 1018. Fiducial markers aredesign to be tracked through modalities such as x-ray, MRI, RF tracking,etc. They provide a surrogate location for the tumor and are generallytracked back to their position at the time of simulation for treatment.These fiducial markers include, but are not limited to, gold seedmarkers, Calypso Beacons, other x-ray markers, MRI markers, etc. asknown to one skilled in the art. The markers may be embedded in theaccessory device to enable the identification of the location as well asorientation of the accessory device. The use of at least three markersmay also enable three-dimensional triangulation of the position of thetumor. For example, a plurality of x-ray opaque markers, preferablythree or four, may be associated with an accessory device configured forinsertion in the mouth and each ear to allow interpolation of thelocation of a tumor in the cranium. These markers may be coupled to theaccessory devices, the thermoplastic material, or any other feature ofthe systems according to the present invention. For example referring toFIG. 15B, a plurality of accessory devices (1018, 1118) are illustratedin the installed condition and comprise one accessory device 1018,having a lock portion 1019 for oral insertion and two accessory devices1118 each having a lock portion 1119 for insertion in each ear of thepatient 1200. Each of the accessory devices may include at least onefiducial marker to identify the relative locations of the accessorydevices, thereby triangulating the position of the patient's head. FIG.15B also shows a base plate (1120) that the low temperature sheet (1122)may be attached to, such that the low temperature thermoplastic sheet630 is proximal to a patient.

Accessory devices of this invention may be produced by any means knownto those of skill in the art. For example, the accessory devices may bemanufactured through any number of 3D printing methods. 3D printingprovides a way of enabling the production of a patient specificaccessory devices. Digital patient anatomy data may be used to developthe custom geometry for a patient fixation portion of the accessorydevices and may be acquired through a number of methods, including butnot limited to optical scanning, laser scanning, x-ray data, CT data,and MRI data. This data is often provided in the form of a DICOM dataset and may be stored for multiple patients in a database of patientspecific accessory devices. The data may be provided in any number offormats including, but not limited to, standard CAD formats. The patientspecific portion of the accessory device may be designed using the datafrom the scanned patient. The design of the locking feature and patientspecific portion could then be coupled using software. Additionaldesired features could then be added or designed using the software. Forexample, in the case of a mouthpiece, a custom tongue or epiglottisblocking feature may be desirable. The channels for a vacuum enhancedbite block may also be included in this way. Once the digital accessorydevice design has been completed, it would then be printed by the 3Dprinter.

Although the description of this invention has concentrated on theapplication to radiation therapy, it is to be understood that theinvention also applies for applications such as neurosurgery,occupational therapy, orthotic devices, plastic surgery, etc. whereenhanced positioning or immobilization are required.

While preferred embodiments of the invention have been shown anddescribed herein, it will be understood that such embodiments areprovided by way of example only. Numerous variations, changes andsubstitutions will occur to those skilled in the art without departingfrom the spirit of the invention. Accordingly, it is intended that theappended claims cover all such variations as fall within the spirit andscope of the invention.

What is claimed is:
 1. An accessory device configured to position apatient relative to an immobilization device including a low temperaturethermoplastic sheet, the accessory device comprising: a patient fixationportion configured for fixation on or insertion into the patient duringuse; and a lock portion extending distally from the patient fixationportion generally along a lock portion axis; wherein the accessorydevice is configured to be engaged by and to contact a proximal surfaceof the low temperature thermoplastic sheet by forming the proximalsurface of the low temperature thermoplastic sheet around the lockportion of the accessory device, such that the proximal surface of thelow temperature thermoplastic sheet conforms to the lock portion andwhen engaged prevents unintended separation of the accessory device fromthe low temperature thermoplastic sheet during use; wherein whenengaged, the lock portion does not penetrate the low temperaturethermoplastic sheet from the proximal surface of the low temperaturethermoplastic sheet to a distal surface of the low temperaturethermoplastic sheet; wherein the proximal surface of the low temperaturethermoplastic sheet is positionable proximal the patient and the distalsurface of the low temperature thermoplastic sheet is opposite from theproximal surface; and wherein the accessory device has an air passagesuch that air may pass through the accessory device.
 2. The accessorydevice according to claim 1, wherein the lock portion comprises anengaging end portion extending from the patient fixation portion, theengaging end portion having a variable cross-sectional area along andorthogonal to the lock portion axis.
 3. The accessory device accordingto claim 2, wherein the lock portion further comprises a stem portionextending from the patient fixation portion to the engaging end portion.4. The accessory device according to claim 1, wherein the lock portiondefines at least one ridge.
 5. The accessory device according to claim1, wherein the lock portion defines at least one notch.
 6. The accessorydevice according to claim 1, wherein the lock portion defines at leastone hole.
 7. The accessory device according to claim 1, wherein the lockportion includes at least one projection extending transverse to thelock portion axis.
 8. The accessory device according to claim 7, whereinthe at least one projection comprises a configuration selected from thegroup consisting of a T-shape, a Y-shape, a X-shape, a fan shape, abow-tie shape, a ring shape, an oblong shape, a rhombus shape, arectangle, and a circle.
 9. The accessory device according to claim 7,wherein the at least one projection extends in a transverse direction.10. The accessory device according to claim 7, wherein the at least oneprojection extends in a superior/inferior direction.
 11. The accessorydevice according to claim 1 further comprising an adhesive coatingapplied to a surface of the engaging end portion.
 12. The accessorydevice according to claim 1 comprising a plurality of lock portionsextending from the patient fixation portion.
 13. The accessory deviceaccording to claim 1, wherein the patient fixation portion comprises amouthpiece.
 14. The accessory device according to claim 13, wherein themouthpiece has a U-shaped configuration.
 15. The accessory deviceaccording to claim 13, wherein the air passage is fluidly connected to apalate vacuum outlet.
 16. The accessory device according to claim 1,wherein the accessory device is a single piece.
 17. The accessory deviceaccording to claim 1, wherein the accessory device further comprises atleast one tongue or epiglottis blocking feature.
 18. The accessorydevice according to claim 1, comprising plural air passages such thatair may pass through the accessory device.